For the First Time Since Pandemic, Some 340B Providers Are Being Audited in Person

HRSA has reconfirmed that it is auditing 340B covered entities for program compliance both remotely and in-person this fiscal year.

The U.S. Health Resources and Services Administration (HRSA) has reconfirmed that it is auditing 340B covered entities for program compliance both remotely and in-person this fiscal year.

HRSA told 340B Report in mid-September that in October it would resume

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CMS Delays Implementing Rule Allowing Multiple Best Prices for Drugs Until Next July

340B provider groups strongly criticized the Centers for Medicare & Medicaid Services’ draft guidance for Medicare drug price negotiations.

The Biden administration said yesterday it is delaying by six months the effective date of a Trump administration final rule to let drug manufacturers report multiple best prices on their products if states opt to participate in value-based purchasing (VBP)

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As Contract Pharmacy Losses Climb into the Billions, Fine for Overcharging 340B Providers Gets Closer to $6,000 Per Instance Mark

HHS OIG has raised the civil monetary penalty for overcharging a 340B covered entity to adjust for inflation.

The federal fine for overcharging a 340B covered entity just went up from $5,883.00 to $5,953.00 per each instance of overcharging.

The U.S. Health and Human Services Department (HHS) Office of Inspector General (OIG) posted its annual inflation adjustments to

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AstraZeneca and Feds Keep Sparring over 340B While Waiting for Judge to Rule

AstraZeneca and the federal government are awaiting the federal district court in Delaware's decision in the company’s 340B contract pharmacy lawsuit.

Drug manufacturer’s AstraZeneca and the federal government continue to joust in court as they await a crucial decision in the company’s 340B contract pharmacy lawsuit.

The two sides on Friday filed a joint status report in Astra’s lawsuit to

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Insulin and Diabetes Drug Makers Ask Judge to Dismiss 340B-Related Antitrust Charges

Insulin and diabetes drug manufacturers want a federal district judge to dismiss 340B-related antitrust changes against them.

U.S. manufacturers of insulin and diabetes-related treatments asked a federal judge on Friday to dismiss two health centers’ antitrust class action over the companies’ denials of 340B pricing when covered entities use contract pharmacies.

In a Nov. 11 joint

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In What Could be the First of Many Challenges, Lilly Appealing U.S. District Court’s 340B Contract Pharmacy Ruling

Lilly yesterday filed notice that it is appealing a federal district judge's decision in its 340B contract pharmacy lawsuit.

Drug manufacturer Eli Lilly late yesterday filed notice that it is appealing a federal district judge’s Oct. 29 ruling partially in Lilly’s favor and partially for the federal government on the legality of Lilly’s denials of 340B ceiling prices when

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In Pursuit of New 340B Leader, HRSA Expands Its Search Beyond Pharmacists

In a major shift, HRSA has dropped its requirement that the Director of the Office of Pharmacy Affairs (OPA) must have a pharmacy degree and be a licensed pharmacist.

In a major organizational change, the U.S. Health Resources and Services Administration (HRSA) has redefined the job of Director of the Office of Pharmacy Affairs (OPA), the HRSA unit that runs the 340B program.

For the first time in 340B

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340B Providers Appear to Escape Bullet as Negotiations Continue on Build Back Better Bill’s Drug Pricing Provisions

The Build Back Better bill is still bogged down by infighting among Democrats, and its numerous drug pricing provisions will likely undergo changes prior to any votes.

Although Congress was able to pass a $1.2 trillion bipartisan infrastructure package last week, the nearly $1.8 trillion Build Back Better bill remains bogged down by infighting among Democrats. Its numerous drug pricing provisions will likely undergo changes prior to

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Attention Turns to Merck and AstraZeneca After Courts’ 340B Contract Pharmacy Rulings

The timing of the government’s forthcoming decision on the legality of Merck’s 340B contract pharmacy policy, and the grounds for its decision, are two big questions hovering over the 340B program.

The smoke is still clearing from three federal district judges’ recent decisions in drug manufacturers Lilly, Sanofi, Novo Nordisk, Novartis, and United Therapeutics’ 340B contract pharmacy lawsuits. In the rulings’ wake, we are keeping close tabs on what happens next

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Hospitals, Drug Manufacturers, and Lawyers Give their Takes on 340B Contract Pharmacy Rulings

A hospital group, drug manufacturers, and health care lawyers gave 340B Report their views on recent court rulings in five 340B contract pharmacy lawsuits.

A hospital group says two federal district judges got it right, but one got it wrong, on whether drug manufacturers are legally bound to provide 340B drug discounts for drugs dispensed at contract pharmacies.

In a Nov. 6 statement, 340B

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